Artificial urinary sphincter device

ABSTRACT

An artificial urinary sphincter device is configured to be implanted in a relationship with a patient&#39;s urethra for the treatment of urinary incontinence. The size and shape of the device can vary for implantation on any of a wide variety of locations relative to the urethra such that it can exert a force onto the urethra for inhibiting or preventing involuntary leakage of urine.

REFERENCE TO PRIORITY DOCUMENT

This application claims priority to U.S. patent application Ser. No.62/136,828, filed on Mar. 23, 2016 and entitled “Artificial UrinarySphincter Device”. Priority to the aforementioned filing date is claimedand the provisional patent application is incorporated herein byreference in its entirety.

BACKGROUND

Urinary incontinence (UI) is a loss of bladder control that results inoccasional or regular leakage of urine out of the bladder in anindividual. It can be a common and distressing condition in that urinaryleakage can occur upon normal movement or action of the person, such aswhen the person coughs or sneezes.

The treatment of urinary incontinence can vary. One type of treatmentinvolves the implantation of an artificial urinary sphincter on to aperson's urethra. There are a variety of disadvantages associated withthe current artificial urinary sphincter. For example, such sphinctersare surgically implanted and such surgery can take a great amount oftime due to the high number of incisions required during implantation.Moreover, existing implants can be formed of several separate piecesthat must be connected together by the surgeon using devices such asclamps, which can be tedious and unwieldy. In addition to being atedious implantation process, the connected pieces can form points offailure for the device after implantation.

In addition, because the device is implanted in tissue, there is atendency for the device to damage or irritate tissue in which it isplanted. The device can also be difficult for patients to actuate, asthe device can be hard to isolate and squeeze. The target audience ofsuch devices are often older patients who can be lacking in dexterity,which can make it even more difficult for such patients to actuate thedevice.

In view of the foregoing, there is a need for improved devices fortreating urinary incontinence.

SUMMARY

An artificial urinary sphincter device is configured to be implanted ina relationship with a patient's urethra for the treatment of urinaryincontinence. The size and shape of the device can vary for implantationon any of a wide variety of locations relative to the urethra such thatit can exert a force onto the urethra for inhibiting or preventinginvoluntary leakage of urine.

In one aspect, there is disclosed an artificial urinary sphincter fortreating urinary incontinence, comprising: a body defining a urethralopening sized and shaped to receive a urethra upon the body beingimplanted into a patient; at least one force member movably attached tothe body, the force member configured to move between a closed positionwherein the force member exerts a force onto the urethra sufficient toinhibit urine flow through the urethra when implanted, and an openposition wherein the force member does not inhibit fluid flow throughthe urethra when implanted; and an actuation assembly coupled to thebody, the actuation assembly including an actuator coupled to anactuation mechanism, wherein the actuation mechanism couples theactuator to the at least one force member so that actuation mechanismcauses movement of the force member between the closed position and theopen position upon actuation of the actuator.

Other features and advantages should be apparent from the followingdescription of various implementations, which illustrate, by way ofexample, the principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of an artificial urinary sphincterdevice.

FIG. 2 shows a side view of the device.

FIG. 3 shows a side view of the device in the open state.

FIG. 4A shows a side view of a casing of the device.

FIG. 4B shows a cross sectional view of a casing of the device.

FIGS. 5A and 5B show the device with a strap member.

FIG. 6 shows a side view of an example skeleton of the device.

FIG. 7 and FIG. 8 show perspective views of the skeleton.

FIG. 9 shows a side view of an example skeleton of the device.

FIG. 10 shows a side view of an example skeleton of the device.

FIGS. 11A and 11B show perspective and side views of an example forcemember of the device.

FIGS. 12A and 12B show perspective and side views of an example forcemember of the device.

FIGS. 13A and 13B show perspective and side views of an example forcemember of the device.

FIG. 14 shows an actuation assembly of the device in an assembled state.

FIG. 15 shows an exploded view of the actuation assembly.

FIG. 16 shows an enlarged view of a button of the actuation assembly.

FIG. 17 shows an enlarged view of a guide piece and a cam member of theactuation assembly.

FIGS. 18 and 19 show an actuation process of the actuation assembly.

FIG. 20 shows a portion of the actuation assembly.

DETAILED DESCRIPTION

An artificial urinary sphincter device is configured to be implanted ina relationship with a patient's urethra for the treatment of urinaryincontinence. The size and shape of the device can vary for implantationon any of a wide variety of locations relative to the urethra such thatit can exert a force onto the urethra for inhibiting or preventinginvoluntary leakage of urine.

In an embodiment, the device is sized and shaped to be implanted on aninferior side of the bulbar urethra in a male subject. In anotherembodiment, the device is sized and shaped to be implanted on a superiorside of the urethra in a female subject. The device is configured totransition between at least two states including (1) a first, closedstate in which the device inhibits or prevents involuntary leakage ofurine through the urethra by exerting a force on the urethra in a mannersufficient to inhibit or prevent urine flow through the urethra; and (2)a second, open state in which the device does not inhibit or preventinvoluntary leakage of urine through the urethra. Either the open stateor the closed state may be a default state of the device. A user cantransition the device between the closed state and the open state byoperating an actuator, such as a button, coupled to the device, asdescribed in more detail below. The button may be located on the deviceor may be remotely located relative to the device.

FIG. 1 shows a perspective view of an artificial urinary sphincterdevice 105, which is formed of an annular or partially annular body orcuff that may have any of a variety of sizes to fit various urethradiameters. The device 105 defines a circular or substantially centralurethral opening 107 sized to receive a urethra such that the device 105can form a ring around the urethra when implanted in a patient. In thisregard, the device 105 includes a gap 109 that provides a passagewaythrough which the urethra can be inserted into the urethral openingduring implantation. The gap 109 provides the device 105 with a C-shape.

The device 105 is formed of an atraumatic, outer membrane or casing 110that at least partially contains an internal, rigid skeleton 115embedded in the casing 110. The casing 110 can be made of a relativelysoft material and can have a rounded, atraumatic shape that does notirritate or damage adjacent tissue when implanted on the urethra. Thecasing 110 can include one or more retaining members, such as wings 112that are sized and shaped to interact with tissue to keep the device ina fixed position relative to tissue once implanted.

The device 105 further includes one or more movable force members 120that are sized, shaped, and positioned to apply pressure to the urethrawhen the device is implanted for inhibiting or preventing involuntaryleakage of urine through the urethra, as described in more detail below.In an embodiment, the force members are configured to compress at leasta portion of the urethra. The device 105 further includes at least onecoupling member such as actuation wires 125 that directly or indirectlyconnects the force members 120 to an actuation assembly for actuatingthe force members 120. In an example embodiment, the actuation assemblyincludes an actuator, such as a button 130, coupled to an actuationmechanism 135 that transitions the force members between open and closedstates upon a user actuating the button 130.

With reference still to FIG. 1, the casing 110 and the skeleton 115provide the general, overall shape of the device's outer periphery. Thecasing 110 forms the rounded, outer periphery of the device 105. The twoforce members 120 are positioned in an opposed relationship such thatthey face one another and extend into or toward the urethral opening 107in a manner that permits them to apply a force to the urethra whenimplanted. The button 130 is positioned along an inferior region of thecasing between the wings 112, which extend outwardly from the outerperiphery of the casing 110. The button 130 is sufficiently large for apatient to locate it and palpate it through the perineum when the deviceis implanted. In order to avoid accidental presses of the button, anoutermost surface of the button (or membrane covering the button) can beflush with an outer surface of the casing 110.

In another embodiment, the actuation assembly including the button 130and actuation mechanism 135 is at least partially positioned in a remotelocation from the casing 110 and skeleton 115.

FIG. 2 shows a side view of the device 105 in the closed state whereinthe force members 120 are separated by a distance such that the forcemembers 120 collectively or individually apply pressure to the urethrawhen the device is implanted. That is, at least a portion of the urethrais positioned between the force members 120 in the implanted device suchthat they can individually or collectively apply pressure to theurethra. FIG. 3 shows a side view of the device 105 in the open statewherein the force members 120 are further separated from one another(relative to the closed state) such that the force members 120 do notapply pressure to the urethra when implanted. A user can actuate thebutton 130 (such as by pressing on the button 130) to transition theforce members 120 between the closed state and the open state. In anon-limiting example, a male user actuates the button 130 by pressing onthe button 130 through the perineum. In another non-limiting example, ina female user, the button is remotely located in an anterior pelvicregion or other anatomically convenient location.

The wires 125 are at least partially disposed in the skeleton 115, asdescribed in more detail below with reference to FIGS. 6-10. The wires125 connect the button 130 to the force members 120 in a manner thatcauses the force members to move between the open state and the closedstate when the button 130 is actuated. For example, when the button ispushed, the wires are forced through wire tracks guide members 615 (FIG.6) in the skeleton 115 in a manner that displaces the force members 120between the open state and close state. In an embodiment, actuation ofthe button 130 transitions the force members 120 between two discretepositions: the open position (shown in FIG. 3) and the closed position(shown in FIG. 2). In this regard, the wires 125 can be considered partof the actuation assembly although they are not necessarily part of theactuation assembly.

The various components of the device 105 are now described in detail. Itshould be appreciated that the structure and assembly of the device 105can vary from the examples described herein and that the device is notlimited to the components described herein.

Casing

As mentioned, the outer periphery of the device is formed by an outercasing 110 that contains the internal skeleton 115. The casing 110 isformed of a relatively soft material that overlies the more rigidskeleton 115, which is sufficiently rigid to provide and maintain thegeneral shape of the device 105.

FIG. 4A shows a side view of the casing 110, which is formed of aC-shaped main body 405 and a pair of wings shaped regions 410 thatdefine the device's wings. The casing 110 is sized and shaped toencompass the skeleton 115 and to provide a soft, smooth, medical gradebarrier between any rigid pieces (such as the skeleton 115 and thebutton number 130) of the device 110 and surrounding tissue when thedevice 110 is implanted in contact with the urethra. The casing 110 canvary in thickness. In an embodiment, the thickness of the casing variesat different locations relative to where the casing 110 is located onthe skeleton. For example, as shown in the cross-sectional view of FIG.4B, the thickness of the casing can vary due to the topography of theskeleton 115 and the circumference of the casing 110. The casing 110 cantaper to a thinner thickness and cross-section in order to accommodatesurrounding tissues and membranes.

A pair of membranes 415 is attached to the casing 110 and positionedinside the urethral opening 107 such that the membranes 415 cover theforce members 120 in the assembled device 105. Another membrane 420 islocated at the position of the button 130, such as on the inferiorsurface of the device 105, and is configured to cover the button 130 inthe assembled device.

The membranes are attached to the casing in a sealed relationship suchthat they cover the force members and the button in a manner sufficientto prevent bodily fluids from entering the device at these locations.The membranes also provide an atraumatic/soft surface over the forcemembers and the button so as to prevent tissue from being pinched bymovement of the mechanisms of the device. The membranes are thin andflexible and are passive in that they do not affect or alter movement ofthe compression pieces or the button. The membranes can be manufacturedin an unsealed relationship with the casing 110 in order to permit thecompression members and the button to be attached to the device. Themembranes can then be sealed to the casing 110 during manufacture toprovide a fluid tight seal.

As mentioned, the casing 110 forms a gap 109 that provides a passagewayfor the urethra to be inserted into the urethral opening 107 during animplantation procedure. In order to bolster or secure the device'splacement or position around the urethra, a strap 505 can be positionedon the device 105 such that the strap 505 covers the gap 109, as shownin FIGS. 5A and 5B. The strap 505 can extend from one side of the outersurface of the casing to an opposite side of the outer surface of thecasing such that it covers the gap 109 and wraps about the superiorsurface of the bulbar urethra. In order to position the strap, a surgeonmay be required to cut through the tunica albuginea during implantationof the device.

The strap 505 can be attached to the device 110 in any of a variety ofmanners. For example, the strap 505 may be molded to the casing 110 onone end and attached on its opposite into the casing using an attachmentmechanism, such as a knob that inserts through a hole in the casingand/or the strap 505. In another example, a knob is pre-positioned onone or more locations on the casing 110 such that a detached strap 505can then be attached to the device 110 by the surgeon by securing thestrap 505 to the knobs such as on opposite ends of the strap 505.

With reference again to FIG. 4A, the wings 112 are extensions, such ascurved extensions, that protrude laterally from the outer periphery ofthe casing 110 at locations near the button 130. In an embodiment, thewings 112 are sized and shaped to cup or otherwise engage the corporalbodies behind the urethra to help prevent the casing 110 from displacingalong or around the urethra during actuation of the device or duringnormal movement of the patient. The wings 112 are made of a flexiblematerial, such as medical grade silicone. The wings 112 can bemanufactured as an integral or monolithic portion of the casing 110. Aconnection location between the casing 110 in the wings 112 can befilleted to provide a strengthened connection.

Skeleton

FIG. 6 shows a side view of an example skeleton 115 of the device 105.FIG. 7 and FIG. 8 show perspective views of the skeleton 115. Theskeleton 115 is a generally annular or partially annular structure thatforms a C-shape. As mentioned, the skeleton 115 is embedded within thecasing 110 in the assembled device. The skeleton 115 is at leastpartially made of a material that is more rigid than the material of thecasing 110 so that the skeleton 115 provides a structurally supportiveframework for the device 105. As mentioned, the outer casing is softerto provide an atraumatic contact surface for the urethra and surroundingtissues. The rigid skeleton 115 maintains the shape of the device 105and its rigidity assists in keeping it in a fixed position around thebulbar urethra. Although the skeleton 115 is rigid, it also has someflexibility to permit the device 105 to be manipulated onto the urethraduring implantation. The flexibility of the skeleton 115 can be achievedvia material properties and/or mechanical properties, such as a hingemechanism on the skeleton 115.

With reference to FIG. 6-8, the skeleton 115 is formed of a base member605 that is positioned on an inferior region of the device. The basemember 605 provides a protective housing for the button 130 and at leasta portion of the actuation assembly. The base member 605 defines a spaceor cavity adequately sized to contain the button 130 and actuationmechanism and also for attachment of the actuation wires 125 to thebutton 130 as well as any other parts of the actuation assembly.

A pair of curved ribs or extensions 610 extend outwardly from the basemember 605. In the example embodiment shown in FIGS. 6-8, the extensions610 are thin, curved strips of material that collectively define agenerally cylindrical shape or C-shape with the gap 109 positionedopposite the base member 605. The extensions 610 provide structuralsupport for the overall shape of the device 110. In this regard, theextensions 610 can have a variety of shapes and sizes adapted to provideproper structural support so that the device can be positioned aroundthe urethra. In an embodiment, the extensions 610 are made of a solidmaterial. In another embodiment, the extensions 610 are made of meshmaterial. It should be appreciated that other materials can be used toform the extensions or any part of the skeleton.

A pair of guide members 615 are disposed along the extensions 610 so asto provide a guide pathway for the actuation wires 125 to run from thebutton 130 to the force members 120 in the assembled device. In theexample embodiment, the guide members 615 are tubular structures eachhaving a first end located at the base member 605 and a second endpositioned along an extension 610. Each guide member 615 defines aninternal lumen with a first opening at the base member 605 and a secondopening at a location where a respective force member 120 is located. Inthis manner, the guide members 615 provide a pathway for the actuationwires to run from the button number 130 to the force members 120. Theguide members 615 provide a protective covering for the actuation wiresand also provide a shield that prevents material wear between theactuation wires and the casing 110. The dimensions of the internallumens of the guide members 615 can vary based on the dimensions of theactuation wires. In an embodiment the internal lumens are only slightlylarger in diameter than the diameter of the wires.

The length of the guide members 615 can vary based upon the location ofthe force members 120 and/or an angle at which the force members 120extend into the opening 107. For example, FIGS. 6-8 show an embodimentwherein the guide members 615 to from the base 605 to about midway ofthe device. In another example embodiment shown in FIG. 9, the guidemembers 615 are longer than the embodiment shown in FIGS. 6-8. It shouldbe appreciated that the guide members 615 can have any of a variety oflengths selected to position the force members at desired locationsand/or orientations.

The actuation wires 125 that run through the guide members may vary inmaterial and in structural configuration. In an example embodiment, thewires are braided wires or spring members. The wires can be made of amaterial that can achieve actuation between the button and the forcemembers without kinking.

As discussed, a gap 109 is located along the periphery of the device105, such as at a superior region of the device. With reference to FIG.10, the skeleton 115 includes this gap 109. The size of the gap 109 canvary and can be larger in the skeleton 115 than in the assembled device105 due to the presence of the casing 110 that overlies the skeleton115. The gap in the skeleton 115 can vary in size and can be defined byan angle ⊖ between a center of the device and the ends of the extensions610. The value of the angle ⊖ may vary and may be selected to provide adesired opening size to accommodate the tunica albuginea when the deviceis implanted. In an embodiment, the angle is less than 90 degrees. Theangle may be large enough to accommodate the urethra during surgery andto accommodate the tunica albuginea while implanted, but small enough todiscourage movement of the device against the urethra.

Force Members

As discussed, the force members 120 are configured to provide a force,such as a compressive force, to the urethra. As shown in FIG. 1, theforce members 120 are positioned facing one another in an opposedrelationship and extending into the urethral opening 107 such that theycan interface with and provide a force to the urethra when the urethrais positioned in the urethral opening 107.

The force members 120 can extend into the opening 107 at any of avariety of angles relative to one another and/or relative to the centerof the device. A magnitude and an orientation of force vector providedby each force member can be selected to provide a desired compression tothe urethra. The force members may press laterally from opposite sideson to the urethra such that the force vectors provided by the forcemembers are parallel and/or coaxial. Alternately, the force vectors canbe nonparallel to one another.

In an embodiment, the actuation assembly maintains the force members ineither the closed state (wherein they compress the urethra to prevent orrestrict urine flow) or the open state (wherein they are positioned toallow urine flow) based on a position of the button 130. Alternately,the force members 120 can be biased toward one of the open state or theclosed state so that the force members are in one of the states as adefault. When in the open state, the force members are slightlypositioned or inserted into the casing 110 such that they do not extendinto the opening 107 or extend only slightly into the opening 107 topermit maximum expansion room for the uncompressed urethra.

The force members 120 can vary in structure. FIGS. 11A and 11B showperspective and side views, respectively, of an example force member120, which has a base 1105 that supports a platform 1110 having anabutment surface that faces and/or contacts the urethra when implanted.In the embodiment of FIG. 11A. The base 1105 is rounded or circular andthe platform 1110 is rectangular with a substantially flat abutmentsurface with chamfered edges. It should be appreciated that the size,shape, and contour of the base 1105, platform 1110, and abutment surfacecan vary to provide a desired amount and type of force to the urethra.For example, FIGS. 12A and 12B show another embodiment wherein theplatform 1110 is shaped to provide a convex abutment surface. In anotherexample embodiment shown in FIG. 13A and 13B, the platform 1110 isshaped to provide a concave abutment surface.

The force members 120 are at least partially made of a material that issufficiently rigid so that they can apply a force to the urethra withoutdeforming. In an embodiment the force members are made of a rigidplastic. The force members 120 can include a softer outer layer ofmaterial, such as silicone, that reduces or eliminates the likelihood ofthe force members damaging the membrane 445 (FIG. 4A) or the urethra. Asmentioned, the force members 120 are mechanically connected to thebutton 130 via the actuation wires, which run through the guide members615 (FIG. 6).

Actuation Assembly

The actuation assembly includes the button 130 and actuation mechanism135. The actuation assembly is actuated to transition the device 105between the open state and the closed state. As mentioned, the actuationassembly is maintained between two discrete states—the open state andthe closed state—based on the position of the button number 130. FIG. 14shows the actuation assembly in an assembled state. FIG. 15 shows anexploded view of the actuation assembly. The assembled actuationassembly is sized and shaped to fit at least partially within the basemember 605 (FIG. 6) of the skeleton 610. When positioned within the basemember 605 of the skeleton 610 of the assembled device, the button 130is oriented and positioned so that a user can exert a force onto thebutton, such as with his or her finger, to actuate the actuationassembly.

The actuation assembly includes the button 130, a cam member 1405, aguide piece 1410, a peg 1415, and a biasing member such as a spring1425. The components of the actuation assembly interlock and/or matewith one another and move relative to one another in a relationship thattransmits motion of the button to motion of the force members 120 viathe actuation wires, which are attached at one end to the button 130 andat an opposite end to the force members 120.

As shown in FIG. 15, a column 1505 extends outwardly from the button 130along an axis A. The guide piece 1410, the cam member 1405, and the peg1415 coaxially aligned with the axis A. FIG. 16 shows an enlarged viewof the button 130. A plurality of cantilevered beams 1510 radiateoutward from the column 1505. In addition, a plurality of structures1520 at an upper region of the column 1505 form several upwardly facing,inclined surfaces. An uppermost end of the column 1505 defines a pair ofstepped surfaces including a lower surface in an upper surface.

FIG. 17 shows an enlarged view of the guide piece 1410 and the cammember 1405. The guide piece 1410 has a substantially cylindrical shapewith spaced apart cutouts or windows 1525 that are positioned to alignwith and receive the cantilevered beams 1510 (FIG. 16) of the button130. The guide piece 1410 has a bottom opening through which the column1505 of the button 130 extends in the assembled actuation assembly withthe cantilevered beams 1510 extending outwardly through the windows 1525of the guide piece 1410, as shown in FIG. 14.

As shown in the enlarged view of FIG. 17, the cam member 1405 also has asubstantially cylindrical shape sized to fit within the guide piece1410. A center opening of the cam member 1405 is coaxial with the axis A(FIG. 15) and is sized to receive the column 1505 of the button 130. Thecam member 1405 has a plurality of slots 1555 that align with andreceive corresponding ribs on internal surfaces of the guide piece 1410.In addition, the cam member 1405 forms a plurality of downwardly facing,inclined surfaces that slidingly engage the upwardly facing, inclinedsurfaces of the column 1505 of the button 130.

With reference again to FIG. 15, the peg 1415 has a column 1560 that iscoaxially aligned with the axis A. A bottom surface of the peg 1415defines a pair of downwardly facing stepped surfaces that engagecomplementary stepped surfaces of the column 1505 of the button 130. Asmentioned, and as shown in FIG. 14, the button 130, cam member 1405,guide piece number 1410, and peg 1415 nest together and coaxiallyaligned along the axis A in the assembled actuation assembly. Whennested as such, the spring 1425 positions over and surrounds the outersurface of the guide piece 1410 with a bottom surface of the spring 1425being supported by the cantilevered beams 1510. In the assembled device,actuation assembly fits in and is housed within the base 605 (FIG. 6) ofthe skeleton with an actuation surface of the button 130 facing outwardfor access by a patient.

The actuation assembly operates as follows. As mentioned, the pushbutton mechanism maintains the two discrete states of the device105—open and closed. The guide piece 1410 enforces the linear motion ofthe other parts of the actuation assembly by virtue of the cantileveredbeams 1510 extending outwardly through the straight windows 1525 of theguide piece 1410. The rotating cam member 1405 locks into two differentpositions along the guide piece 1410: either inside the guide piece 1410(as shown in FIG. 18) or extended out past an upper edge of the guidepiece 1410 (as shown in FIG. 19). The button column 1505 drives therotating cam 1405 into the two different positions by virtue of thesliding engagement between the upwardly facing inclined surfaces on thebutton column 1505 and the downwardly facing inclined surfaces on therotating cam 1405.

The spring 1525, which surrounds the guide piece 1410 (as shown in FIG.14), maintains an upward force so that the two different states are heldin place. The spring 1525 is strong enough to pull the actuation wires125 connected to the force members. The peg 1415 extends through therotating cam 1405 to keep the rotating cam 1405 and the button 130 atthe same relative distance at all times, allowing the actuation wiresattached to the button to follow the two positions of the rotating cam1405 and thereby move the force members 120 between the open and closedstates.

It should be appreciated that the actuation assembly can vary instructure and mechanical configuration and is not limited to the exampleembodiment shown herein.

Assembly of the Device

The device 105 can be provided as a single component, assembled systemto the surgeon. As discussed, the device is formed of several pieces,which are manufactured separately and assembled into the final device.Some non-limiting examples of how the device 105 is assembled are nowdescribed.

The actuation wire 125 and the force members 120 are connected in anexample embodiment by a lock and pull system. A first tip of theactuation wire has a rigid attachment piece 2005 (such as plastic)shaped to mate with a corresponding piece on the force member 120. In anexample, the attachment piece 2005 is T-shaped, as shown in FIG. 20. Atip of the attachment piece 2005 is connected to the actuation wire (notshown in FIG. 20), such as by a small peg at the bottom of the T shape.The tip of the actuation wire is inserted into a slot at the end of theattachment piece 2005 and then manipulated to be pulled/fitted into asecond slot. This connects the force member 120 and the actuation wireso that the mechanism will work when displacement is translated from theactuation wires to the force members. The slots can also be filled inwith a material such as glue after the tip of the actuation wire isplaced into the force member wherein the glue acts as a secondaryconnection system.

The actuation wires 125 connect to the button 130 at locations near thetop of the button, as shown in FIG. 15. The actuation wires can beinserted into openings at the top of the button where the user actuatesthe mechanism and the wire clamped at the end of the guide members toensure that the wires do not shift and that equal displacement istransferred to both force members 120.

The aforementioned assemblies are just example and variations are withinthe scope of this disclosure.

Implantation Procedure

The device 105 is surgically implanted into a patient by inserting thepatient's urethra into the urethral opening of the device. Theimplantation procedure can optionally vary based on whether the patientis male or female.

For female patients, the device 105 can be implanted from an abdominalapproach on the superior surface of the urethra so that the gap 109 ofthe device 105 faces towards the vagina. The device is oriented suchthat thicker portions of the device are situated away from the vaginalwall to discourage erosion. The button and actuation assembly may beplaced elsewhere in the body at a remote location from the device andfrom the urethra just under the skin, such as at the anterior pelvicarea where there is enough back pressure to operate the buttonmechanism.

The actuation wires may be extended from the force members, through therigid guide members of the skeleton, through the base of the skeleton,to the remote location of the actuation assembly. The guide membersremain rigid within the region located inside the casing of the device.However, the guide members can transition to a softer material (such asan elastomer) in the region extending from the casing to the remotebutton. During surgery the surgeon thread the softer guide member andactuation wire under the skin to connect the cuff to the actuationassembly.

For a male patient, the surgeon makes a perineal incision along thesagittal plane and clears away tissues, membranes, and muscle to exposethe bulbar urethra. The surgeon clears space lateral to the urethra oneither side, but does not have to make a blind incision on the superiorside of the urethra to separate the urethra from the tunica albuginea.The surgeon then measures the approximate diameter of the urethra tochoose the appropriate device 105 to implant such that the opening inthe device 105 is proper for the size of the urethra.

The device 105 can be provided in different sizes to accommodatedifferent sized urethras. When the cuff changes in diameter, this may beaccompanied by corresponding changes in the dimensions of the skeleton,actuation wires, force members, and actuation assembly. After dissectingaround the urethra and measuring the diameter of the urethra, thesurgeon chooses the appropriately sized device to implant. To implant,the surgeon carefully pull apart the two sides of the device to expandthe gap 109 and slip the cuff onto the urethra through the gap 109 suchthat the urethra is positioned in the opening. Once the device issecured around the urethra, the surgeon may adjust the position andplacement of the device along the urethra. The surgeon can test thedevice during surgery to ensure sufficient compression is achieved withthe chosen size before closing the incision and ending the surgery.

The surgeon has the option of using the strap (FIGS. 5A and 5B and 6)that wraps completely circumferentially around the urethra. If thesurgeon decides that more security is needed by use of the strap, thesurgeon cuts completely around the urethra and through the tunicaalbuginea. The strap is then secured to one side of the cuff beforebeing threaded behind the urethra and secured on the opposite side ofthe cuff.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

1. An artificial urinary sphincter for treating urinary incontinence,comprising: a body defining a urethral opening sized and shaped toreceive a urethra upon the body being implanted into a patient; at leastone force member movably attached to the body, the force memberconfigured to move between a closed position wherein the force memberexerts a force onto the urethra sufficient to inhibit urine flow throughthe urethra when implanted, and an open position wherein the forcemember does not inhibit fluid flow through the urethra when implanted;an actuation assembly coupled to the body, the actuation assemblyincluding an actuator coupled to an actuation mechanism, wherein theactuation mechanism couples the actuator to the at least one forcemember so that actuation mechanism causes movement of the force memberbetween the closed position and the open position upon actuation of theactuator.
 2. An artificial urinary sphincter as in claim 1, wherein thebody comprises an outer casing and an internal skeleton at leastpartially disposed inside the outer casing.
 3. An artificial urinarysphincter as in claim 2, wherein the internal skeleton is more rigidthan the outer casing.
 4. An artificial urinary sphincter as in claim 2,wherein the outer casing is made of silicone.
 5. An artificial urinarysphincter as in claim 1, wherein the body is annular.
 6. An artificialurinary sphincter, wherein the body is annular and has a gap thatprovides a passageway for the urethra to be inserted into the urethralopening.
 7. An artificial urinary sphincter as in claim 1, wherein thebody at least partially surrounds the urethra when implanted.
 8. Anartificial urinary sphincter as in claim 1, further comprising aretaining member on the body, wherein the retaining member interactswith adjacent tissue in a manner that fixes a position of the artificialurinary sphincter relative to tissue when implanted.
 9. An artificialurinary sphincter as in claim 8, wherein the retaining member is a wingthat extends outwardly from the body.
 10. An artificial urinarysphincter as in claim 1, wherein the at least one force member comprisesa pair of force members each having an abutment surface that facestoward the urethral opening.
 11. An artificial urinary sphincter as inclaim 10, wherein the pair of force members face toward one another. 12.An artificial urinary sphincter as in claim 1, wherein the at least oneforce members moves inward toward the urethral opening as it transitionsfrom the open position to the closed position.
 13. An artificial urinarysphincter as in claim 1, wherein the at least one force members movesaway from the urethral opening as it transitions from the closedposition to the open position.
 14. An artificial urinary sphincter as inclaim 1, wherein the force member exerts a force onto the urethrasufficient to completely block urine flow through the urethra whenimplanted and in the closed position.
 15. An artificial urinarysphincter as in claim 10, wherein the at least one force membercomprises an abutment surface that is at least one of a flat surface, acurved surface, a concave surface, and a convex surface.
 16. Anartificial urinary sphincter as in claim 10, wherein the pair of forcemembers exert parallel force vectors toward the urethra.
 17. Anartificial urinary sphincter as in claim 10, wherein the pair of forcemembers exert nonparallel force vectors toward the urethra.
 18. Anartificial urinary sphincter as in claim 1, wherein the actuator of theactuation assembly is a button.
 19. An artificial urinary sphincter asin claim 18, wherein the button can be pressed to transition the atleast one force member between the open position and the closedposition.
 20. An artificial urinary sphincter as in claim 1, wherein theactuation assembly is contained within the body.
 21. An artificialurinary sphincter as in claim 1, wherein at least a portion of theactuation assembly is outside the body.
 22. An artificial urinarysphincter as in claim 1, wherein the actuator is remotely locatedrelative to the body.
 23. An artificial urinary sphincter as in claim 1,further comprising an actuator wire that mechanically attaches theactuator to the at least one force member.
 24. An artificial urinarysphincter as in claim 23, wherein the actuator wire is part of theactuation assembly.
 25. An artificial urinary sphincter as in claim 23,wherein the body comprises an outer casing and an internal skeleton atleast partially disposed inside the outer casing, and wherein theactuator wire extends through the internal skeleton.
 26. An artificialurinary sphincter as in claim 24, wherein the internal skeleton includesa tubular guide member having an internal lumen through which theactuator wire extends.